MOUNTAINEER OCT SPINAL SYSTEM

MOUNTAINEER OCT SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K132332) manufactured by Medos International SARL. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2013. Regulation: 8.